Digital Certificates for the FDA ESG
The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of regulatory information for review.
The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach their final destination. It does not open or review submissions; it automatically routes them to the proper FDA Center or Office.
Intesi Group’s digital certificates are FDA compliant
The digital certificate allow users to submit data through ESG and has a high level of security, binding to the individual’s name and email address.
| Meets ESG requirements | |
| Support | Email, help desk ticket |
| Validity | 3 Years* |
| Price | 120 € |
Intesi Group digital certificates for FDA ESG submissions can be used for WebTrader or AS2 account, depending on your company’s option. For the complete list of submission types exchanged with ESG, please check the FDA official website.
In addition to that, according to the latest FDA guidances to address coronavirus pandemic (effective March 2020), certain categories of products/components or medical devices can benefit for an accelerated procedure thorugh FDA ESG, 510(k) submissions.
Check out here the updated list of COVID-19 related guidance documents published by FDA.
More information regarding FDA ESG portal
For more information regarding FDA ESG portal and how to use your digital certificate for electronic submissions, please visit the dedicated FDA webpages:
https://www.fda.gov/industry/about-esg/esg-appendix-c-digital-certificates#4
https://www.fda.gov/industry/electronic-submissions-gateway
https://www.fda.gov/industry/about-esg/esg-submission-process
